Trial from ANZCTR


Trial ID ACTRN12607000106437
Trial Status: Registered
Date Submitted: 8/12/2006
Date Registered: 6/02/2007
Retrospectively registered

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Public title Can macadamia nuts be part of a weight loss diet?
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Study title in 'Participant- Intervention- Comparator- Outcome (PICO)' format The effects of long-term ingestion of macadamia nuts on weight control in overweight subjects
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UTN
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Trial acronym M.E.D.O.W. (Macadamia Enriched Diets for OverWeight subjects)
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Health condition(s) or problem(s) studied:
Obesity 1600 0
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Condition category: Condition code:
Diet and nutrition Obesity
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1703 1703 0 0

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Descriptions of intervention(s) / exposure A description of the study: Once recruited, subjects will be randomly assigned to either a test pre-entry diet or control group. The test pre-entry ‘loading’ group will have their usual (baseline) diet assessed to determine their overall energy intake and percentage contribution of energy nutrients as well as fatty acid (FA) composition. Based on the percentage of their dietary fat intake, Macadamia nut and oil products will be provided to substitute a major proportion (~20%) of the usual source of dietary fat without affecting total daily energy intake, i.e. isocaloric with usual baseline diet. This pre-entry ‘loading’ phase will continue for a period of 10 weeks, after which time subjects from each of the test pre-entry ‘loading’ diet and control groups will be randomly assigned to one of two different energy-controlled weight reduction diets.

In the energy-controlled (second) phase of the trial, the test diet will consist of moderately high fat intake (35-40%) with a large proportion (~20%) derived from macadamia nuts. Each diet will be progressively adjusted to facilitate a reduction in body weight of 0.5-1.0 kg per week.

The test period will endure 6 months duration in the first instance, with subjects being monitored regularly over a period of up to 18 months. This protocol will involve regular face-to-face consultations over this time to enable collection of samples and present opportunities to sustain adherence to the dietary protocol. Specifically visits at 0, 1, and 4 weeks, followed by two-monthly visits during the weight loss protocol will be conducted for subject monitoring. Additional consultation will be provided as required for each subject. Dietary data in the form of 3-day food records, 24 hour dietary recall and food frequency questionnaires will be taken to monitor adherence.

Non-invasive anthropometric measures (BMI, waist and hip circumference, bioelectrical impedance) and endothelial function tests will be conducted as well. Blood samples will be taken both to screen for subject eligibility and to provide information on risk factors such as serum lipids, markers of inflammation and to cross-validate dietary data. A proportion of samples will be allocated to low temperature storage to enable retrospective biochemical analysis.

Pre-Entry Intervention Group: Usual diet modified to allow for pre-determined amount of macadamia nuts.

Weight Loss (energy-controlled) Phase Intervention Group: a moderately high fat (close to 35% of energy) monounsaturated fat-enriched, energy-controlled, weight loss diet including a pre-determined amount of macadamia nuts daily.
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Intervention Code:
Prevention 1492 0
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Comparator / control treatment Pre-Entry Control Group: Usual diet. In the energy-controlled (second) phase of the trial, The control diet will be a moderately low fat diet (20-25%) aligned with the American Heart Association (AHA) Step II Diet. Diet will be progressively adjusted to facilitate a reduction in body weight of 0.5-1.0 kg per week.
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Control group Active
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Primary Outcome: Weight loss 2364 0
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Timepoint: 2364 0
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Primary Outcome: Amelioration of Cardiovascular risk profile, which will be assessed by tracking a range of demonstrated pre-disposing factors including:
- Body weight in relation to body mass index
2365 0
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Timepoint: Measured at baseline, 10 weeks, 14 weeks, monthly for 6 months of weight loss trial, then two-monthly until trial exit. 2365 0
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Primary Outcome: Amelioration of Cardiovascular risk profile, which will be assessed by tracking a range of demonstrated pre-disposing factors including:
- Body Composition in relation to Body Mass Index
2366 0
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Timepoint: Mmeasured at baseline, 10 weeks, 14 weeks, monthly for 6 months of weight loss trial, then two-monthly until trial exit 2366 0
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Primary Outcome: Amelioration of Cardiovascular risk profile, which will be assessed by tracking a range of demonstrated pre-disposing factors including:
- Body composition using waist-hip ratio and bio-electrical impedance as routine measures
2367 0
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Timepoint: Measured at baseline, 10 weeks, 14 weeks, monthly for 6 months of weight loss trial, then two-monthly until trial exit 2367 0
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Primary Outcome: Amelioration of Cardiovascular risk profile, which will be assessed by tracking a range of demonstrated pre-disposing factors including:
- Biochemical risk factors for atherosclerosis: serum triglycerides, total cholesterol, high density lipoprotein cholesterol (HDL) and low density lipoprotein cholesterol (LDL)
2368 0
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Timepoint: Measured at baseline, at 10 weeks, 6 months and at trial exit 2368 0
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Primary Outcome: Amelioration of Cardiovascular risk profile, which will be assessed by tracking a range of demonstrated pre-disposing factors including:
- Biochemical risk factors for Myocardial Infarction: inflammatory predisposition (C-reactive protein)
2369 0
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Timepoint: Measured at baseline, 10 weeks, 6 months, and at trial exit 2369 0
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Primary Outcome: Amelioration of Cardiovascular risk profile, which will be assessed by tracking a range of demonstrated pre-disposing factors including:
- Physiological risk factor for Myocardial Infarction: endothelial function measured via flow-mediated brachial artery vasodilation
2370 0
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Timepoint: Measured at baseline, 10 weeks, 6 months, and at trial exit 2370 0
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Primary Outcome: Amelioration of Cardiovascular risk profile, which will be assessed by tracking a range of demonstrated pre-disposing factors including:
- Behavioural risk factors: dietary intake and physical activity
2371 0
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Timepoint: Measured at baseline, monthly for 9 months, then every 2nd month 2371 0
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Secondary Outcome: Anthropometric measures (body weight, waist-hip ratio). 4119 0
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Timepoint: Measured at baseline, 10 weeks, 14 weeks, monthly for 6 months of weight loss trial, then two-monthly until trial exit. 4119 0
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Secondary Outcome: High Density Lipoprotein (HDL) & Low Density Lipoprotein (LDL) cholesterol, total cholesterol, triglycerides, inflammation markers. 4120 0
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Timepoint: All measured at baseline, at 10 weeks, 6 months and at trial exit. 4120 0
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Secondary Outcome: Body composition (bioelectrical impedance) 4121 0
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Timepoint: Measured at baseline, 10 weeks, 14 weeks, monthly for 6 months of weight loss trial, then two-monthly until trial exit. 4121 0
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Secondary Outcome: Brachial artery vasodilation 4122 0
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Timepoint: Measured at baseline, 10 weeks, 6 months, and at trial exit. 4122 0
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Key inclusion criteria BMI 27-50 kg/m2; waist circumference F= >88 cm, M= >102 cm; non-smoker >1 year; blood pressure systole >100 and <140 mmHg, diastole <90mmHg; total fasting cholesterol less than 260mg/dl; total fasting triglycerides less than 400 mg/dl; total fasting glucose less than 126 mg/dl; normal liver and kidney function; willing to modify diet and other health behaviours; not planning to become pregnant or move during the study; have no food allergies to nut products; subjects must not be currently following any particular diet and must not have intentionally lost weight by dieting during the previous 3 months; subjects must not be taking nutritional supplements other than a daily multivitamin (or be willing to stop taking nutritional supplements if needed); subjects must be willing to maintain current physical activity routine, which cannot exceed the equivalent of >30 minutes per day or moderate-intensity activity; Blood hematocrit normal; subjects must be willing to comply with all study-related procedures; not using medication (insulin or oral) to control blood sugar.
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Minimum age 26 Years
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Maximum age 55 Years
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Gender Both males and females
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Healthy volunteers? No
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Key exclusion criteria Any medical condition that may make weight loss medically inadvisable; history of kidney failure or disease; cancer diagnosis within 2 years prior to study entry; consumption of more than 3 alcoholic drinks a day; type I or type II diabetes; current use of hypolipidemics, anti-psychotics; hypoglycaemics, glucocorticoids or thyroid medication; plan to move during the study; current participation in another clinical trial; pregnancy or breast-feeding; liver disease; high cholesterol; diabetes; HIV positive; Syphilis; Hepatitis B/C positive; does not meet age requirement; habitual smoker; food allergies; unwillingness to provide written consent; personal history of cardiovascular disease, including prior myocardial infarction, angioplasty, or bypass surgery; known cardiovascular or metabolic disease; currently using medications to control blood pressure, lipids or glucose; currently on diet or attempted weight loss by dieting in last 3 months; currently exercising more than the equivalent of 30 minutes/day or moderate intensity physical activity; currently on oral contraceptives; history of alcohol or drug abuse; known allergy or sensitivity to nuts; known atherosclerotic cardiovascular disease; history of congestive heart failure; history of non skin malignancy in previous 5 years or skin malignancy in previous 2 years; any major active rheumatologic, pulmonary, hepatic, renal, dermatologic disease or inflammatory condition; history of HIV positive; weight loss inducing medications or dietary supplements within 3 months prior to enrolment; weight loss > 5kg in last 6 months; serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject’s safety or successful participation in the study.
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Study type Interventional
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Purpose of the study Prevention
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Allocation to intervention Randomised controlled trial
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Describe the procedure for enrolling a subject and allocating the treatment (allocation concealment procedures) Sealed envelopes are held by an independent person, and opened by the independent person to assign the intervention group.
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Describe the methods used to generate the sequence in which subjects will be randomised (sequence generation) Computer-generated random numbers (Excel), in blocks at entry, subjects are randomised twice: to pre-entry and weight loss phases of study
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Masking / blinding Open (masking not used)
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Who is / are masked / blinded (choose all that apply)


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Assignment Parallel
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Other design features
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Type of endpoint(s) Efficacy
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Statistical Methods/Analysis
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Phase
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Anticipated date of first participant enrolment 8/12/2006
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Date of first participant enrolment
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Anticipated date last participant recruited/enrolled
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Actual date last participant recruited/enrolled
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Target sample size 60
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Recruitment status Recruiting
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Recruitment in Australia

Recruitment state(s)
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Recruitment outside Australia

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Funding Source: Charities/Societies/Foundations 1849 0
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Name: Horticulture Australia 1849 0
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Address: 1849 0
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Country: Australia 1849 0
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Primary Sponsor University
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Name: Griffith University
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Country: Australia
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Secondary Sponsor: University 1664 0
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Name: University of Queensland 1664 0
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Address: 1664 0
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Country: Australia 1664 0
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Has the study received approval from at least one Ethics Committee? Yes
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Ethics Committee name: Griffith University 3448 0
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Address: 3448 0
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Country: Australia 3448 0
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Approval Date: 07/11/2005 3448 0
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Submitted Date: 3448 0
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HREC: PBH/09/05/HREC 3448 0
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Brief summary This study will determine if macadamia nuts are an appropriate food to include in diets to address weight loss and other factors associated with coronary heart disease.
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Trial website
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Trial related presentations / publications
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Public Notes
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Principal Investigator
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Contact person for public queries
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Name: Dr. Shawn Somerset
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Address: School of Public Health Griffith University University Drive Meadowbrook QLD 4131
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Country: Australia
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Tel: +61 7 33821027
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Fax: +61 7 33821034
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Email: s.somerset@griffith.edu.au
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Contact person for scientific queries
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Name: Dr. Shawn Somerset
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Address: School of Public Health Griffith University University Drive, Meadowbrook. 4131
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Country: Australia
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Tel: +61 7 33821027
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Fax: +61 7 33821034
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Email: s.somerset@griffith.edu.au
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